KR910005888B1 - 동결건조 b형 간염 왁진의 제조방법 - Google Patents
동결건조 b형 간염 왁진의 제조방법 Download PDFInfo
- Publication number
- KR910005888B1 KR910005888B1 KR1019840003814A KR840003814A KR910005888B1 KR 910005888 B1 KR910005888 B1 KR 910005888B1 KR 1019840003814 A KR1019840003814 A KR 1019840003814A KR 840003814 A KR840003814 A KR 840003814A KR 910005888 B1 KR910005888 B1 KR 910005888B1
- Authority
- KR
- South Korea
- Prior art keywords
- hbsag
- wax
- hepatitis
- solution
- lyophilized
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 208000002672 hepatitis B Diseases 0.000 title claims description 16
- 238000000034 method Methods 0.000 title description 12
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 26
- 229910052782 aluminium Inorganic materials 0.000 claims description 26
- 238000004108 freeze drying Methods 0.000 claims description 22
- 239000000203 mixture Substances 0.000 claims description 16
- 239000000427 antigen Substances 0.000 claims description 12
- 102000036639 antigens Human genes 0.000 claims description 12
- 108091007433 antigens Proteins 0.000 claims description 12
- 239000003381 stabilizer Substances 0.000 claims description 11
- 239000007864 aqueous solution Substances 0.000 claims description 8
- 241000700721 Hepatitis B virus Species 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 239000000499 gel Substances 0.000 description 31
- 239000000243 solution Substances 0.000 description 30
- 239000001993 wax Substances 0.000 description 27
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 15
- 239000000047 product Substances 0.000 description 13
- VSCWAEJMTAWNJL-UHFFFAOYSA-K aluminium trichloride Chemical compound Cl[Al](Cl)Cl VSCWAEJMTAWNJL-UHFFFAOYSA-K 0.000 description 10
- 150000003839 salts Chemical class 0.000 description 10
- 239000000725 suspension Substances 0.000 description 10
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 9
- 238000003860 storage Methods 0.000 description 9
- 229940024546 aluminum hydroxide gel Drugs 0.000 description 8
- SMYKVLBUSSNXMV-UHFFFAOYSA-K aluminum;trihydroxide;hydrate Chemical compound O.[OH-].[OH-].[OH-].[Al+3] SMYKVLBUSSNXMV-UHFFFAOYSA-K 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- 230000007935 neutral effect Effects 0.000 description 8
- 239000002504 physiological saline solution Substances 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 8
- 235000018102 proteins Nutrition 0.000 description 8
- 102000004169 proteins and genes Human genes 0.000 description 8
- 108090000623 proteins and genes Proteins 0.000 description 8
- 239000006228 supernatant Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- 239000000463 material Substances 0.000 description 6
- 239000012153 distilled water Substances 0.000 description 5
- 238000005259 measurement Methods 0.000 description 5
- 238000003127 radioimmunoassay Methods 0.000 description 5
- 239000001509 sodium citrate Substances 0.000 description 5
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 description 4
- 239000000969 carrier Substances 0.000 description 4
- 230000007423 decrease Effects 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000012931 lyophilized formulation Substances 0.000 description 4
- 239000003755 preservative agent Substances 0.000 description 4
- 239000012088 reference solution Substances 0.000 description 4
- 210000002966 serum Anatomy 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 239000011550 stock solution Substances 0.000 description 4
- 241000700198 Cavia Species 0.000 description 3
- 108010010803 Gelatin Proteins 0.000 description 3
- 235000001014 amino acid Nutrition 0.000 description 3
- 150000001413 amino acids Chemical class 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 239000000872 buffer Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 150000004676 glycans Chemical class 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 229920001282 polysaccharide Polymers 0.000 description 3
- 239000005017 polysaccharide Substances 0.000 description 3
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 3
- 229940033663 thimerosal Drugs 0.000 description 3
- 239000004475 Arginine Substances 0.000 description 2
- SRBFZHDQGSBBOR-IOVATXLUSA-N D-xylopyranose Chemical compound O[C@@H]1COC(O)[C@H](O)[C@H]1O SRBFZHDQGSBBOR-IOVATXLUSA-N 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- 102000008100 Human Serum Albumin Human genes 0.000 description 2
- 108091006905 Human Serum Albumin Proteins 0.000 description 2
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 2
- 229940024545 aluminum hydroxide Drugs 0.000 description 2
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 2
- 238000004166 bioassay Methods 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 239000013024 dilution buffer Substances 0.000 description 2
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 2
- 230000035931 haemagglutination Effects 0.000 description 2
- 238000003018 immunoassay Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 238000011081 inoculation Methods 0.000 description 2
- 238000004255 ion exchange chromatography Methods 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 239000012669 liquid formulation Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000002953 phosphate buffered saline Substances 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- 239000001488 sodium phosphate Substances 0.000 description 2
- 238000001179 sorption measurement Methods 0.000 description 2
- 238000007619 statistical method Methods 0.000 description 2
- 229960004793 sucrose Drugs 0.000 description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 2
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 2
- 235000019801 trisodium phosphate Nutrition 0.000 description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- GXCDLJXPZVCHBX-UHFFFAOYSA-N 3-methylpent-1-yn-3-yl carbamate Chemical compound CCC(C)(C#C)OC(N)=O GXCDLJXPZVCHBX-UHFFFAOYSA-N 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 229930091371 Fructose Natural products 0.000 description 1
- 239000005715 Fructose Substances 0.000 description 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 1
- 239000004471 Glycine Substances 0.000 description 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- KEAYESYHFKHZAL-UHFFFAOYSA-N Sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 235000004279 alanine Nutrition 0.000 description 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 description 1
- PYMYPHUHKUWMLA-UHFFFAOYSA-N arabinose Natural products OCC(O)C(O)C(O)C=O PYMYPHUHKUWMLA-UHFFFAOYSA-N 0.000 description 1
- 235000009697 arginine Nutrition 0.000 description 1
- SRBFZHDQGSBBOR-UHFFFAOYSA-N beta-D-Pyranose-Lyxose Natural products OC1COC(O)C(O)C1O SRBFZHDQGSBBOR-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
- AIYUHDOJVYHVIT-UHFFFAOYSA-M caesium chloride Chemical compound [Cl-].[Cs+] AIYUHDOJVYHVIT-UHFFFAOYSA-M 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 238000000432 density-gradient centrifugation Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 235000013681 dietary sucrose Nutrition 0.000 description 1
- 150000002016 disaccharides Chemical class 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229930182830 galactose Natural products 0.000 description 1
- 238000001641 gel filtration chromatography Methods 0.000 description 1
- 238000012812 general test Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229930195712 glutamate Natural products 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 230000016784 immunoglobulin production Effects 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000000644 isotonic solution Substances 0.000 description 1
- 235000018977 lysine Nutrition 0.000 description 1
- 229910001629 magnesium chloride Inorganic materials 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 150000002772 monosaccharides Chemical class 0.000 description 1
- LPUQAYUQRXPFSQ-DFWYDOINSA-M monosodium L-glutamate Chemical compound [Na+].[O-]C(=O)[C@@H](N)CCC(O)=O LPUQAYUQRXPFSQ-DFWYDOINSA-M 0.000 description 1
- 239000004223 monosodium glutamate Substances 0.000 description 1
- 235000013923 monosodium glutamate Nutrition 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229940021222 peritoneal dialysis isotonic solution Drugs 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000012086 standard solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000820 toxicity test Toxicity 0.000 description 1
- 238000005199 ultracentrifugation Methods 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
- 238000004018 waxing Methods 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/29—Hepatitis virus
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2730/00—Reverse transcribing DNA viruses
- C12N2730/00011—Details
- C12N2730/10011—Hepadnaviridae
- C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
- C12N2730/10122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Virology (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Biochemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Communicable Diseases (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP83-122945 | 1983-07-05 | ||
| JP58122945A JPS6013718A (ja) | 1983-07-05 | 1983-07-05 | Ｂ型肝炎ワクチン |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR850002277A KR850002277A (ko) | 1985-05-10 |
| KR910005888B1 true KR910005888B1 (ko) | 1991-08-06 |
Family
ID=14848502
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1019840003814A Expired KR910005888B1 (ko) | 1983-07-05 | 1984-07-02 | 동결건조 b형 간염 왁진의 제조방법 |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP0130619B1 (enrdf_load_stackoverflow) |
| JP (1) | JPS6013718A (enrdf_load_stackoverflow) |
| KR (1) | KR910005888B1 (enrdf_load_stackoverflow) |
| AT (1) | ATE41309T1 (enrdf_load_stackoverflow) |
| AU (1) | AU572162B2 (enrdf_load_stackoverflow) |
| CA (1) | CA1237076A (enrdf_load_stackoverflow) |
| DE (1) | DE3477139D1 (enrdf_load_stackoverflow) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60193925A (ja) * | 1984-03-13 | 1985-10-02 | Chemo Sero Therapeut Res Inst | 凍結乾燥製剤化ワクチン |
| EP0294071A3 (en) * | 1987-06-03 | 1990-08-01 | Merck & Co. Inc. | Hepatitis b vaccines made with pre-formed aluminum hydroxide gels, and processes thereof |
| AU4315693A (en) * | 1992-05-23 | 1993-12-30 | Smithkline Beecham Biologicals (Sa) | Combined vaccines comprising hepatitis b surface antigen and other antigens |
| AU4932493A (en) * | 1992-09-25 | 1994-04-26 | Dynagen, Inc. | An immunobooster for delayed release of immunogen |
| US6290967B1 (en) * | 1996-12-20 | 2001-09-18 | Merck & Co., Inc. | Stabilizers for lyophilized vaccines |
| US6051238A (en) * | 1996-12-20 | 2000-04-18 | Merck & Co., Inc. | Stabilizers for lyophilized mumps vaccines |
| BR0111494A (pt) * | 2000-06-08 | 2004-01-13 | Powderject Vaccines Inc | Pó de livre escoamento formador de gel adequado para uso como uma vacina, processo para a preparação do mesmo, receptáculo de dosagem para uma seringa sem agulha, seringa sem agulha, composição de vacina, método para vacinação de um indivìduo, pó adequado para uso como uma vacina, e, processo para a preparação do mesmo |
| UA79735C2 (uk) | 2000-08-10 | 2007-07-25 | Глаксосмітклайн Байолоджікалз С.А. | Очищення антигенів вірусу гепатиту b (hbv) для використання у вакцинах |
| US7229645B2 (en) | 2001-06-08 | 2007-06-12 | Powderject Research Limited | Spray freeze-dried compositions |
| KR20030025480A (ko) * | 2001-09-21 | 2003-03-29 | 보령제약 주식회사 | 약독화 수두 생바이러스 백신용 무단백질 안정화제 |
| US20060228369A1 (en) * | 2005-04-11 | 2006-10-12 | Program For Appropriate Technology In Health | Stabilization and preservation of temperature-sensitive vaccines |
| EP1933867A1 (en) | 2005-10-04 | 2008-06-25 | Alk-Abello A/S | Solid vaccine formulation |
| WO2008057550A2 (en) | 2006-11-07 | 2008-05-15 | Sanofi Pasteur Biologics Co. | Stabilization of vaccines by lyophilization |
| TW201043267A (en) * | 2009-03-19 | 2010-12-16 | Intervet Int Bv | In situ constituting a vaccine for administration to a predetermined herd of animals |
| GB2499480A (en) * | 2010-03-31 | 2013-08-21 | Stabilitech Ltd | Method for preserving alum adjuvants and alum-adjuvanted vaccines |
| HUE033656T2 (en) | 2010-03-31 | 2017-12-28 | Stabilitech Ltd | Binders for stabilizing virus particles |
| JP5960120B2 (ja) | 2010-03-31 | 2016-08-02 | スタビリテック リミテッド | ウイルス粒子の安定化 |
| WO2012177970A1 (en) | 2011-06-24 | 2012-12-27 | Merck Sharp & Dohme Corp. | Hpv vaccine formulations comprising aluminum adjuvant and methods of producing same |
| WO2013012022A1 (ja) | 2011-07-19 | 2013-01-24 | 中外製薬株式会社 | アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 |
| GB201117233D0 (en) | 2011-10-05 | 2011-11-16 | Stabilitech Ltd | Stabilisation of polypeptides |
| JP5931449B2 (ja) * | 2012-01-11 | 2016-06-08 | 日東電工株式会社 | 医薬組成物及びその製造方法 |
| GB201406569D0 (en) | 2014-04-11 | 2014-05-28 | Stabilitech Ltd | Vaccine compositions |
| CN109069817B (zh) * | 2016-04-15 | 2021-07-13 | 富士胶片株式会社 | 微针阵列 |
| GB2562241B (en) | 2017-05-08 | 2022-04-06 | Stabilitech Biopharma Ltd | Vaccine compositions |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2879202A (en) * | 1954-11-05 | 1959-03-24 | American Cyanamid Co | Stabilization of live viral vaccines by hexahydric alcohols |
| DE1617457A1 (de) * | 1966-12-16 | 1972-04-20 | Erba Carlo Spa | Verfahren zur Stabilisierung von Zubereitungen interferierender Virusprodukte |
| DE1617350C3 (de) * | 1967-06-22 | 1979-09-06 | Behringwerke Ag, 3550 Marburg | Verfahren zur Inaktivierung von biologischem Material |
| US3636191A (en) * | 1969-10-08 | 1972-01-18 | Cancer Res Inst | Vaccine against viral hepatitis and process |
| JPS5523253B2 (enrdf_load_stackoverflow) * | 1973-12-28 | 1980-06-21 |
-
1983
- 1983-07-05 JP JP58122945A patent/JPS6013718A/ja active Granted
-
1984
- 1984-06-28 AU AU29993/84A patent/AU572162B2/en not_active Ceased
- 1984-07-02 KR KR1019840003814A patent/KR910005888B1/ko not_active Expired
- 1984-07-04 EP EP84107773A patent/EP0130619B1/en not_active Expired
- 1984-07-04 AT AT84107773T patent/ATE41309T1/de not_active IP Right Cessation
- 1984-07-04 DE DE8484107773T patent/DE3477139D1/de not_active Expired
- 1984-07-05 CA CA000458226A patent/CA1237076A/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| KR850002277A (ko) | 1985-05-10 |
| CA1237076A (en) | 1988-05-24 |
| ATE41309T1 (de) | 1989-04-15 |
| AU2999384A (en) | 1985-01-10 |
| DE3477139D1 (en) | 1989-04-20 |
| EP0130619A2 (en) | 1985-01-09 |
| AU572162B2 (en) | 1988-05-05 |
| JPH0437806B2 (enrdf_load_stackoverflow) | 1992-06-22 |
| JPS6013718A (ja) | 1985-01-24 |
| EP0130619A3 (en) | 1985-04-10 |
| EP0130619B1 (en) | 1989-03-15 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| KR910005888B1 (ko) | 동결건조 b형 간염 왁진의 제조방법 | |
| KR100491281B1 (ko) | 저당함량을가지는안정한알부민무함유재조합인자Vlll의제제 | |
| EP1308170B1 (en) | Dried blood factor composition comprising trehalose | |
| JP5752671B2 (ja) | Ｖｅｇｆアンタゴニスト製剤 | |
| JP3031570B2 (ja) | 安定化されたゴナドトロピンを含有する調製品 | |
| JPH089547B2 (ja) | 改良された静脈内投与可能な免疫性グロブリン組成物 | |
| US8216588B2 (en) | Lyophilized preparation comprising influenza vaccine, and method for preparation thereof | |
| US20010051603A1 (en) | Dried blood factor composition comprising trehalose | |
| JP2636499B2 (ja) | プラスミノーゲン活性化因子蛋白の薬学的組成物 | |
| WO2006023665A2 (en) | Il-1 antagonist formulations | |
| JPH01279843A (ja) | 凍結乾燥ａ型肝炎ワクチン | |
| EP0391444A2 (en) | Interleukin-1 Formulation | |
| WO2009079837A1 (fr) | Formulation pharmaceutique contenant une protéine de fusion sérum albumine humaine recombinante-interféron alpha | |
| JPH05306235A (ja) | パラサイロイドホルモン類の安定化組成物 | |
| JPS62153224A (ja) | プラスミノゲン製剤 | |
| KR100260634B1 (ko) | B형 간염 백신의 제조방법 | |
| JPH06211691A (ja) | プラスミノゲン乾燥製剤 | |
| MXPA97005209A (es) | Preparacion estabilizada de factor viii recombinante, libre de albumina, que tiene un bajo contenido de azucares | |
| HK1117766A (en) | Dried blood factor composition stabilised by trehalose | |
| JP2001081040A (ja) | 組織プラスミノーゲンアクティベーター含有組成物 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PA0109 | Patent application |
Patent event code: PA01091R01D Comment text: Patent Application Patent event date: 19840702 |
|
| PG1501 | Laying open of application | ||
| A201 | Request for examination | ||
| PA0201 | Request for examination |
Patent event code: PA02012R01D Patent event date: 19890224 Comment text: Request for Examination of Application Patent event code: PA02011R01I Patent event date: 19840702 Comment text: Patent Application |
|
| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
Comment text: Notification of reason for refusal Patent event date: 19910410 Patent event code: PE09021S01D |
|
| G160 | Decision to publish patent application | ||
| PG1605 | Publication of application before grant of patent |
Comment text: Decision on Publication of Application Patent event code: PG16051S01I Patent event date: 19910711 |
|
| E701 | Decision to grant or registration of patent right | ||
| PE0701 | Decision of registration |
Patent event code: PE07011S01D Comment text: Decision to Grant Registration Patent event date: 19911026 |
|
| GRNT | Written decision to grant | ||
| PR0701 | Registration of establishment |
Comment text: Registration of Establishment Patent event date: 19911101 Patent event code: PR07011E01D |
|
| PR1002 | Payment of registration fee |
Payment date: 19911101 End annual number: 3 Start annual number: 1 |
|
| PR1001 | Payment of annual fee |
Payment date: 19940701 Start annual number: 4 End annual number: 4 |
|
| PR1001 | Payment of annual fee |
Payment date: 19950705 Start annual number: 5 End annual number: 5 |
|
| PR1001 | Payment of annual fee |
Payment date: 19960702 Start annual number: 6 End annual number: 6 |
|
| PR1001 | Payment of annual fee |
Payment date: 19970625 Start annual number: 7 End annual number: 7 |
|
| PR1001 | Payment of annual fee |
Payment date: 19980630 Start annual number: 8 End annual number: 8 |
|
| PR1001 | Payment of annual fee |
Payment date: 19990629 Start annual number: 9 End annual number: 9 |
|
| PR1001 | Payment of annual fee |
Payment date: 20000624 Start annual number: 10 End annual number: 10 |
|
| PR1001 | Payment of annual fee |
Payment date: 20010704 Start annual number: 11 End annual number: 11 |
|
| PR1001 | Payment of annual fee |
Payment date: 20020708 Start annual number: 12 End annual number: 12 |
|
| FPAY | Annual fee payment |
Payment date: 20030627 Year of fee payment: 13 |
|
| PR1001 | Payment of annual fee |
Payment date: 20030627 Start annual number: 13 End annual number: 13 |
|
| EXPY | Expiration of term | ||
| PC1801 | Expiration of term |